Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01897701 | A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1 | PHASE1 | COMPLETED | 280 | — | — | Jul 1, 2013 | Aug 1, 2014 | Oct 13, 2014 | 3 | Australia |
Number (and percentages) of subjects with solicited local and systemic AEs over the seven days post-injection and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 35 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year post-second injection.
* Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | High dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 \& 21 |
| Group B | EXPERIMENTAL | Intermediate dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 \& 21 |
| Group C | EXPERIMENTAL | Intermediate dose Monovalent Avian Influenza VLP (H7N9) and Low dose Adjuvant 1; IM; Day 0 \& 21 |
| Group D | EXPERIMENTAL | Low dose Monovalent Avian Influenza VLP (H7N9) and Low dose Adjuvant 1; IM; Day 0 \& Day 21 |
| Group E | EXPERIMENTAL | Intermediate dose Monovalent Avian Influenza VLP (H7N9) and High dose Adjuvant 1; IM; Day 0 \& 21 |
| Group F | EXPERIMENTAL | Low dose Monovalent Avian Influenza VLP (H7N9) and High dose Adjuvant 1; IM; Day 0 \& 21 |
| Group G | EXPERIMENTAL | Placebo; IM; Day 0 \& 21 |
| Name | Type | Description |
|---|---|---|
| Monovalent Avian Influenza VLP (H7N9) | BIOLOGICAL | - |
| Adjuvant 1 | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: Subjects must meet all of the following to be eligible for participation in the study: 1. Healthy adult male or female, ≥18 years of age, 2. Willing and able to give informed consent prior to study enrollment, 3. Able to comply with study requirements, and 4. Women of childbear...